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Rheumatology Practice Management June 2017 Vol 5 No 3 - Clinical Trials Tracker

The following clinical trials represent a selection of key studies that are currently recruiting patients with fibromyalgia for inclusion in investigations of new therapies and new regimens of existing treatments for individuals with the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help rheumatology practice managers and providers direct their eligible patients to one of these clinical trials.

1. Behavioral versus Analgesic Therapy in Patients with Fibromyalgia

The objective of this randomized, double-blind, phase 3 clinical trial is to compare the use of pharmacologic treatment with behavioral health therapy in patients with fibromyalgia. Patients aged 21 to 70 years with a diagnosis of fibromyalgia and who are not currently using tramadol may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive a combination of tramadol plus cognitive behavioral therapy, tramadol plus health education, placebo plus cognitive behavioral therapy, or placebo plus health education.

The primary outcome measure is a change in mean pain severity, based on 5 days of daily pain diaries and changes in physical function assessed via the Fibromyalgia Impact Questionnaire-Revised. This study expects to enroll 250 patients at the University of Rochester, NY, and the University of Washington, Seattle. For more information, contact Caitlin M. Sheffels, BA, at 206-221-1737 or csheff@uw.edu, or Robert Dworkin, PhD, at Robert_Dworkin@URMC.rochester.edu. The NLM Identifier is NCT01598753.

2. Suvorexant versus Placebo in Patients with Fibromyalgia and Comorbid Insomnia

This randomized, double-blind, crossover, phase 4 clinical trial will compare the use of short-term suvorexant with placebo in patients with fibromyalgia and comorbid insomnia, with a focus on sleep, pain, and daytime sleepiness/fatigue. Patients aged 21 to 65 years with fibromyalgia diagnosed in accordance with the American College of Rheumatology (ACR) criteria, and an insomnia diagnosis that meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive suvorexant or placebo.

The primary outcome measure is polysomnographic assessment of total sleep time, based on a standard 8-hour sleep recording. The secondary outcome measure is daytime pain sensitivity. This study expects to enroll 30 patients at the Henry Ford Health System, Sleep Disorders Center, Detroit, MI. For more information, contact Dana Withrow, MHA, at 313-916-5302 or dwithro2@hfhs.org, or Gail Koshorek, BS, at 313-916-5179 or gkoshor1@hfhs.org. The NLM Identifier is NCT02684136.

3. Effects of Low-Level Laser Therapy on Pain, Fatigue, and Physical Function

The objective of this randomized, double-blind, parallel-assignment clinical trial is to evaluate the use of low-level laser therapy for its effects on pain, fatigue, and physical function in patients with fibromyalgia. Patients aged 18 to 80 years with fibromyalgia who do not have any other pain syndromes that anatomically overlap with fibromyalgia pain, and who are not currently using photosensitive medication may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive active or sham laser treatment.

The primary outcome measure is the Symptom Impact Questionnaire. Secondary outcome measures include the 36-Item Short Form Survey for quality of life, the Global Rating of Change Scale, and the Medication Usage Scale. This study expects to enroll 60 patients at the McDermott Pain Management Clinic, Dallas, TX. For more information, contact Jason Zafereo, PT, PhD, at 214-648-1002 or jason.zafereo@utsouthwestern.edu. The NLM Identifier is NCT02948634.

4. Viability of Auricular Percutaneous Electrical Neural Field Stimulation

This randomized, single-blind, parallel-assignment, early phase 1 clinical trial will examine the feasibility of using auricular percutaneous electrical neural field stimulation in the treatment of patients with fibromyalgia. Right-handed veterans aged 20 to 60 years with fibromyalgia diagnosed in accordance with the ACR 2010 criteria, and who do not have severe anxiety, claustrophobia, or other conditions that may inhibit their ability to lie in a magnetic resonance imaging (MRI) scanner may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive standard therapy (ie, physical therapy, medication management, and referral to a pain psychologist) or percutaneous electrical neural field stimulation via a military field stimulator device.

The primary outcome measure is functionally correlated neural substrates of pain in patients undergoing percutaneous electrical neural field stimulation, determined via a functional connectivity MRI. Secondary outcome measures include the Defense and Veterans Pain Rating Scale, analgesic consumption, and functional tests. This study expects to enroll 20 patients at the Atlanta VA Medical and Rehab Center, Decatur, GA. For more information, contact Anna Woodbury, MD, at Anna.Woodbury@va.gov. The NLM Identifier is NCT03008837.

5. Safety and Analgesic Efficacy of ASP0819 in Patients with Fibromyalgia

The objective of this randomized, double-blind, parallel-assignment, phase 2a clinical trial is to evaluate the safety and analgesic efficacy of using ASP0819 in the treatment of patients with fibromyalgia. Patients aged 18 to 80 years with fibromyalgia diagnosed in accordance with the ACR 2010 criteria, and who have a body mass index ≤45 kg/m2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ASP0819 or placebo.

The primary outcome measures include changes in mean daily average pain score from baseline to week 8, the occurrence of treatment-emergent adverse events, and the Colombia-Suicide Severity Rating Scale. Secondary outcome measures include patient responses from baseline to week 8 and end of treatment, and overall improvement. This study expects to enroll 178 patients at multiple locations across the United States. For more information, contact Astellas Pharma Global Development at 800-888-7704 (ext. 5473) or astellas.registration@astellas.com. The NLM Identifier is NCT03056690.

6. Transcranial Direct Current Stimulation for Fibromyalgia Pain Management

This randomized, double-blind, parallel-assignment clinical trial will define the effects of cognitive behavioral therapy and anodal transcranial direct current stimulation over left dorsolateral prefrontal cortex—as monotherapies and in combination—for the treatment of pain in patients with fibromyalgia. Patients aged 21 to 85 years who have been diagnosed with fibromyalgia in accordance with the ACR criteria for ≥1 years, and who are not currently receiving chronic opioid therapy may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive active or sham transcranial direct current stimulation.

The primary outcome measure is quantitative sensory testing. Secondary outcome measures include the Beck Depression Inventory, the McGill Pain Questionnaire, and the Fibromyalgia Impact Questionnaire. This study expects to enroll 72 patients at the Medical University of South Carolina, Charleston. For more information, contact Jeffrey Borckardt, PhD, at 843-792-3295 or borckard@musc.edu. The NLM Identifier is NCT02723175.

7. Safety and Efficacy of Duloxetine in Patients with Juvenile Primary Fibromyalgia Syndrome

The objective of this randomized, parallel-assignment, phase 3 clinical trial is to evaluate the safety and efficacy of using duloxetine for the treatment of adolescent patients with juvenile primary fibromyalgia syndrome. Patients aged 13 to 17 years with juvenile primary fibromyalgia syndrome who have a Brief Pain Inventory average pain severity score of ≥4 at screening and no pain symptoms relative to a traumatic injury, past surgery, or structural bone or joint disease that could interfere with the interpretation of outcome measures may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive duloxetine or placebo; during the open-label extension portion of the trial all patients will receive duloxetine.

The primary outcome measure is changes in Brief Pain Inventory modified short form-adolescent version 24-hour average pain severity item from baseline to week 13. Secondary outcome measures include changes in Pediatric Pain Questionnaire item scores, Functional Disability Inventory child scale and rent scale, and Children’s Depression Inventory, from baseline to week 13, and baseline to week 39. This study expects to enroll 210 patients at multiple locations across the United States and abroad. For more information, call 877-285-4559 or 317-615-4559. The NLM Identifier is NCT01237587.

8. Transcutaneous Electrical Nerve Stimulation in Patients with Fibromyalgia

This randomized, factorial-assignment, phase 2 clinical trial will evaluate the use of transcutaneous electrical nerve stimulation in patients with fibromyalgia. Women aged 18 to 70 years who have been diagnosed with fibromyalgia in accordance with the ACR 1990 criteria, have a history of fibromyalgia-associated cervical or lumbar pain, and have not used transcutaneous electrical nerve stimulation in the past 5 years may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive active or placebo transcutaneous electrical nerve stimulation, or standard care (ie, only receiving transcutaneous electrical nerve stimulation in the last 4 weeks of the trial).

The primary outcome measure is pain with movement. Secondary outcome measures are function and quality of life, pressure pain threshold, conditioned pain modulation, and Patient-Reported Outcomes Measurement Information System. This study expects to enroll 360 patients at the University of Iowa, Iowa City, and Vanderbilt University, Nashville, TN. For more information, contact Kathleen A. Sluka, PT, PhD, at 319-335-9791 or slukalab@uiowa.edu, or Dana L. Dailey, PT, PhD, at 319-335-7149. The NLM Identifier is NCT01888640.

9. Propranolol for the Treatment of Pain in Patients with Fibromyalgia

The objective of this randomized, parallel-assignment, phase 1 clinical trial is to assess the practicality of using low-dose propranolol for the treatment of patients with fibromyalgia. Women aged 18 to 65 years who have been diagnosed with fibromyalgia in accordance with the ACR 1990 and 2010 criteria, and who have no known cardiovascular diseases may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive propranolol or placebo.

The primary outcome measure is changes in self-reported clinical pain via the Revised Fibromyalgia Impact Questionnaire. The secondary outcome measure is changes in the Patient-Reported Outcomes Measurement Information System. This study expects to enroll 30 patients at the University of Utah, Salt Lake City. For more information, contact Yuri Kida, MSW, at 801-585-7697 or yuri.kida@hsc.utah.edu, or Reiko Mitsunaga, RN, at 801-585-7695 or reiko.mitsunaga@hsc.utah.edu. The NLM Identifier is NCT03029845.

10. Customized Electro-Acupuncture versus Auricular-Acupuncture for Managing Fibromyalgia Pain

This randomized, parallel-assignment clinical trial will compare 2 kinds of acupuncture with usual care for the treatment of chronic pain in patients with fibromyalgia and other musculoskeletal conditions. Patients aged ≥18 years who have musculoskeletal pain that is regional (ie, joints, extremities, back, neck) or generalized (ie, fibromyalgia or chronic widespread pain) may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive electro- or auricular-acupuncture, or standard care and pain management.

The primary outcome measure is pain intensity and pain interference, determined via the Brief Pain Inventory. This study expects to enroll 360 patients at the Memorial Sloan Kettering Cancer Center, New York. For more information, contact Jun Mao, MD, MSCE, at 646-888-0808, or Ting Bao, MD, at 646-888-0865. The NLM Identifier is NCT02979574.

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Last modified: July 26, 2017
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